(83 days)
The Spine-Tech™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The Spine-Tech™ Cement Restrictor is NOT intended for any spinal indications.
The Spine-Tech™ Cement Restrictor is a threaded, hollow cylinder that is manufactured from PEEK Optima LT1 with carbon fiber. This device is intended to be used in conjunction with PMMA cement.
The provided text describes a 510(k) premarket notification for a medical device (Spine-Tech™ Cement Restrictor), focusing on its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics typically found in clinical trials or validation studies for AI/algorithm-based devices.
Therefore, most of the requested information cannot be extracted from this document.
Here's an assessment based on the provided text, indicating what information is not available:
1. Table of acceptance criteria and the reported device performance:
- Not available. This document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than setting or meeting specific performance acceptance criteria from a study.
2. Sample size used for the test set and the data provenance:
- Not available. No test set or data provenance from a study is mentioned. The clearance is based on comparison to predicate devices, not specific performance data from a clinical or analytical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available. No ground truth establishment for a test set is mentioned.
4. Adjudication method for the test set:
- Not available. No test set or adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not available. This device is a physical medical implant (cement restrictor), not an AI or imaging diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not available. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not available. No ground truth for a study is mentioned. The "ground truth" for 510(k) clearance is often the historical performance (safety and efficacy) of the predicate device(s).
8. The sample size for the training set:
- Not available. No training set is mentioned as this is not an AI/algorithm device.
9. How the ground truth for the training set was established:
- Not available. No ground truth for a training set is mentioned.
Summary based on the document:
The Spine-Tech™ Cement Restrictor received 510(k) clearance based on demonstrating substantial equivalence to two predicate devices:
- RPX™ Titanium Cement Restrictor Device (K020344)
- Medtronic Sofamor Danek Cement Restrictor PEEK Optima™ LT (K010528)
Equivalence was established based on:
- Similarities of intended use: Both the subject device and predicates are intended for use as cement restrictors in orthopedic surgeries (e.g., femoral canal and tibial plateau in hip stem and total knee replacement).
- Design similarities: All are cement restrictors. The subject device is a threaded, hollow cylinder manufactured from PEEK Optima LT1 with carbon fiber.
- Physical characteristics similarities: Implied by the design and material, without specific physical characteristic data provided in this summary.
The FDA added a warning that the device is not intended for any spinal indications, and its safety and effectiveness when implanted in the spine have not been established. This indicates an assessment of where the device could potentially be used but its safety and efficacy are not proven for that specific use.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.